EMA accused of putting pharma profits before patients

_Regulators are "protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data", according to researchers in articles published by the BMJ.

__They call for full access to full trial reports, both published and unpublished, "to allow the true benefits and harms of treatments to be independently assessed by the scientific community." Peter Gotzsche and Dr Anders Jorgensen from the Nordic Cochrane Centre in Denmark write that _despite the existence of hundreds of thousands of clinical trials, "doctors are unable to choose the best treatments because research results are being reported selectively".

They claim that selective reporting can have "disastrous consequences". For example, they say Merck & Co's now-withdrawn painkiller Vioxx (rofecoxib) has "probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s".

Three-year 'struggle' to get unpublished data

The authors go on to describe what they call a three-year struggle to access unpublished trial reports for two anti-obesity drugs, Sanofi-Aventis now-withdrawn Acomplia (rimonabant) and Roche's Xenical (orlistat), submitted by the manufacturers to the European Medicines Agency.

This information "was important for patients because anti-obesity pills are controversial,” they say, and "people have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been de-registered for safety reasons".

__However, Prof Gotzsche and Dr Jorgensen claim the EMA refused access, arguing that this would undermine "commercial interests and that there was no overriding public interest in disclosure". They also cited the "administrative burden involved and the worthlessness of the data after they had edited them". __The authors appealed to the European ombudsman, who criticised the EMA’s refusal to grant access. But only after the ombudsman accused the agency of maladministration did the regulator agree to widen public access to documents.

'Fundamentally wrong'

__“There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients,” say Prof Gotzsche and Dr Jorgensen. _They call on other drug regulatory agencies to follow suit and suggest that access should be prompt and that documents should be provided in a useful format to allow for independent scrutiny.

“Drug agencies should get rid of the huge paper mountains and require electronic submissions from the drug companies, including the raw data, which should also be made publicly available,” they conclude. __

In an accompanying editorial, researcher Andrew Vickers of the Memorial Sloan-Kettering Cancer Center, New York says "the system is broken and needs fixing". He describes a new initiative by the Wellcome Trust to tackle the problem by developing principles for funders with regard to data sharing, and suggests that the medical research community “get used to it.”

__He argues that once medical researchers start publishing their data, and depositing it in data archives, "they will discover not only that it is painless, but that it affords huge advantages to medical science, and to patients present and future."__The BMJ added that it believes "systematic efforts are needed to assess this largely unexamined threat to the integrity of evidence-based medicine".